Drugs

Lilly Warns of Risk in Compounded Tirzepatide/Vitamin B12

Eli Lilly has issued a “public warning” about potential safety risks associated with compounded tirzepatide (Mounjaro and Zepbound) with vitamin B12. A company statement says Lilly tested compounded products being marketed to Americans that contain tirzepatide combined with B12, sometimes referred to as methylcobalamin, hydroxcobalamin, or cyanocobalamin. It says the testing revealed significant levels of an impurity resulting from a chemical reaction between tirzepatide and the vitamin.

“The impurity … is concerning because nothing is known about its short- or long-term effects in humans, the potential impact on the drug’s interaction with the GLP-1 and GIP receptors, toxicity, immune reactions, or how it is absorbed, distributed, metabolized, and eliminated,” the warning says. “The risks to patients are unknown because tirzepatide has never been studied in combination with B12, and the compounders making these combination drugs are not required to monitor or report adverse events. People receiving tirzepatide/B12 products from compounders, telehealth companies, medspas, or anyone else should be aware that they may be using a potentially dangerous product with unknown risks.”

Lilly says it sent its test findings to FDA and recommends that people using the untested products contact their doctors for advice and to discuss alternate treatment options.

The company says this warning is the latest in its ongoing effort to highlight the risk of mass compounded versions of its tirzepatide medications.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome